Specialist, Compounding Operations Documentation

The role

The Compounding Operations Documentation Specialist is responsible for the creation, review, control, and continuous improvement of documentation related to compounding activities. This role ensures accurate and compliant recording of batch production activities and supports documentation practices in alignment with compliance and quality systems.

What you will do

• Draft, revise, and format manufacturing documentation including SOPs, work instructions, logs, forms, and compounding protocols.
• Ensure document revisions are properly controlled, approved, and issued.
• Maintain documentation archives and ensure real-time filing and retrieval.
• Align documentation activities with regulatory requirements and internal QMS standards.
• Maintain compliance with USP 795, 800, 503A, and other regulatory guidelines.
• Participate in audits and inspections by preparing and presenting documents.
• Support data integrity initiatives and adherence to ALCOA+ principles.
• Collaborate with production and quality teams for continuous improvement.
• Partner with compounding operators and supervisors to identify training points.
• Help transition paper-based processes to electronic formats.

Required qualifications

• Bachelor’s degree in English / Communications, Technical Writing / Tech Comm Pharmaceutical Technology, Chemistry, Pharmacy or a related field.
• Strong knowledge of USP 795 and 800, cGMP, GDP, and compliance.
• Detail-oriented with excellent proofreading and technical writing skills.
• Proficiency in Google Suite.
• Experience in Asana, SmartSheet.
• Gowning and entry into classified cleanroom areas.
• Wearing Personal Protective Equipment (PPE) including gloves, respiratory protection, and gown.
• Medical approval to wear respiratory protection including N95, full face respirator, SCBA, or PAPR.
• Walking up to 50% of the time.
• Standing up to 100% of the time.
• Squatting and bending up to 20% of the time.
• Lifting up to 50lbs.

Nice to have

• Working familiarity with compounding processes, equipment, and terminology.
• Experience in electronic batch records (EBR) and manufacturing execution systems (MES).
• Ability to handle multiple priorities with a strong sense of urgency and accuracy.
• Strong interpersonal and communication skills.
• Good Manufacturing Practices (cGMP) experience.
• 3–5 years of experience in a cGMP manufacturing environment, preferably with compounding or formulation experience.
• Document control systems (e.g., MasterControl, Veeva, Agile) experience.

Benefits

• Competitive salary & equity compensation
• Unlimited PTO
• Company holidays
• Quarterly mental health days
• Comprehensive health benefits including medical, dental & vision
• Parental leave
• Employee Stock Purchase Program (ESPP)
• 401k benefits with employer matching contribution
• Offsite team retreats

Before you apply

• Must be willing to wear Personal Protective Equipment (PPE) for the length of working with Hazardous Drugs (HD).
• Requires medical approval to wear respiratory protection.
• Must be willing to confirm understanding of potential risks (teratogenicity, carcinogenicity and reproductive effects) of handling hazardous drugs.

About the company

Hims & Hers is a health and wellness platform that provides access to personalized, affordable, and accessible care. It is a public company traded on the NYSE.